LF51906119061

SOCRSystem User GuidePage 1 of 27 Revision B April 2013Medtronic Confidential Sensor Optimization of CRT Response (SOCR) System User Guide Caution:Investigational device. Limited by federal law (USA) toinvestigational use. Exclusively for clinicalinvestigations. Investigational Device / Instrument de recherche. To Be Used by Qualified InvestigatorsOnly / Réservé uniquement à l'usagede chercheurs compétents. Approval date: 4.0 DSN009462 22-Apr-2013 16:05 UTC Rev. SOCRSystem User GuidePage 2 of 27 Revision B April 2013Medtronic Confidential SYMBOLS DEFINITIONS: Attention, consult accompanying documents. Device is type CF, direct cardiac applied parts. Caution or Warning notice. Do not reuse, single patient use only. Conformité Européenne (European Conformity). This symbol means that the device fully complies with R&TTE Directive 1999/5/EC. Do not dispose of this product in the unsorted municipal waste stream. Dispose of the product according to local regulations. TERMINOLOGY DEFINITIONS: TermDefinition SubjectPatient under study. ImpedanceRatio of voltage measured divided by current injected. VectorPacing lead electrode configuration for impedance measurement. Approval date: 4.0 DSN009462 22-Apr-2013 16:05 UTC Rev. SOCRSystem User GuidePage 3 of 27 Revision B April 2013Medtronic Confidential Table of Contents 1. Physical Characteristics.................................................................................4 1.1System Components..........................................................................4 1.2Power Source......................................................................................4 1.3IntendedUse Environment................................................................5 2. System Overview...........................................................................................6 2.1System Description............................................................................6 2.2Intended Use.......................................................................................8 2.2.1Intended Use of the Model 19061 AHM Module................................8 2.2.2Intended Use of the Model 19062 Heart Sound Sensor Device........8 2.2.3Intended Use of the Model 15420 Patient Cable...............................9 2.3Cleaning and Maintenance................................................................9 2.4Warnings and Precautions................................................................9 2.5Potential Adverse Events................................................................10 2.6Contraindications.............................................................................10 3. System Setup..............................................................................................11 3.1Biopac System Overview.................................................................11 3.2 Connections to the Biopac System................................................12 3.3Connections to and Use of the AHM Module.................................13 3.4Connections to the Subject.............................................................15 3.5Installing and Uninstalling the SOCR Investigational Software...16 3.6Starting the SOCR Investigational Software ..................................16 3.7Software Setup for the AHM Module...............................................17 3.7.1Programming Impedance Vectors...................................................19 3.8Software Setup for the Heart Sound Sensor Device.....................20 4. Setup Test Procedure..................................................................................21 Appendix A – Installing the SOCR Investigational Software...............................22 Appendix B – Uninstalling the SOCR Investigational Software...........................25 Approval date: 4.0 DSN009462 22-Apr-2013 16:05 UTC Rev. SOCRSystem User GuidePage 4 of 27 Revision B April 2013Medtronic Confidential 1. PHYSICAL CHARACTERISTICS 1.1SYSTEM COMPONENTS Components included as part of the SOCR research system are shown inTable 1. Table 1.System Components ComponentDescription Investigational Model 19061 AHM Module Impedance measurement and pacing component Investigational Model 19062 Heart Sound SensorDevice Heart sounds component BiopacMP150and UIM100CData acquisition system Model 2090 Programmer with Viva/BravaSoftwarewith 2090 A/B and cable Programmer forHeart Sound SensorDevice Model 2090 Programmer with SOCR Investigational Softwarewith 2090 A/B and cable Programmer for AHM Module Laptop Computerwith AcqKnowledge Software package Used for data acquisition software Investigational Model 15420 Patient Cable Used for connectionof AHM Moduleto subjectpacing leads RA/RV leadsConnections to subject right heart LV lead or LV catheter/patient cableConnections to subject left heart Millarpressure catheterLV pressure component Millar PCU-2000and patient cableLV pressure measurement component 1.2POWER SOURCE The AHM Moduleis powered by six 3.6V AA lithiumbatteries. A set of batteries will provide at least 4-hours of procedure time before requiring replacement. These batteries will be provided by Medtronic to centers for use in the study.The Heart Sound SensorDevice has a self-contained battery. All other system components requiring power (i.e. the laptop, Biopac MP150, and the 2090 Programmers) will use AC line power. Caution: It is recommended that the AHM Modulebe fitted with a fresh set of 3.6V AA lithiumbatteriesprovided by Medtronicprior to each clinical case. Approval date: 4.0 DSN009462 22-Apr-2013 16:05 UTC Rev. SOCRSystem User GuidePage 5 of 27 Revision B April 2013Medtronic Confidential Caution:It is recommended that the SOCRSystembe disconnected from the subjectduring battery replacement. Caution: The 2090 Programmer is powered with AC line power. Caution: The BiopacMP150 Data Acquisition System is powered with AC line power. Caution: The laptop computer is powered with AC line power. 1.3INTENDED USE ENVIRONMENT T…

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WTD 13.4.9 FCC Compliance Opinion MDTR0202 Information about the Applicant Grantee (Company Name) Medtronic Inc. FCC Contact Person Charles Farlow Address 8200 Coral Sea St. City, State, Zip Mounds View, MN 55112 Job Number MDTR0202 Model Acute Human Monitor FCC ID LF519061 Agent Approval Type Original Equipment Class DCD Part 15, low power Tx below 1.705 MHz Rule Part unlicensed 15.209 Overview The model 19061 is an Acute Human Monitor used in clinical studies only and not available to the public. The Acute Human Monitor module is a component being used as part of a Clinical Study System in the Electrophysiology Lab. It uses inductive telemetry to communicate with an FCC approved implant, FCC ID: LF5MICSIMPLANT3 Confidentiality requested for allowed files. Request is properly addressed and referenced. Special confidentiality requested and granted by the FCC for internal photos exhibit. No short term confidentiality requested. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 5/29/2013

M E F C R G P b L I c P M M E May 29, 2013 Equipment A ederal Comm Colu mbia, M Regarding: App Gentlemen: Please find e ID:LF51906 being used a intracardiac It uses induc LF5MICSIM If you have contact via e Sincerely, Principal Radi Medtronic, Inc 8200 Coral Se Mounds View, Email:janet.g.g Office:763-536 Calif: 650-585 3 Authorization munications MD 21046 plication for cer enclosed an 61 that will b as part of a C impedence ctive telemet MPLANT3. any question email at jane o/Telecom Reg c. a St. N.E. , MN 55112 gavidia@medtr 6-2373 5-7077 n Branch Commissio rtification for F application be used for C Clinical Stud and hear sou try to comm ns regarding et.g.gavidia@ gulatory Affair ronic.com on FCC ID: LF51 for certificat Clinical Stud dy System in unds signals municate with this applica @medtronic. rs 9061 tion of an M dy use only. n the Electrop during the d h designated ation, please com. Medical Acut The AHM M physiology ( defined acute implant app feel call me te Human M Module is a (EP) Lab for e human stu proved under e at 650-585- Monitor, FCC component r continuous udy protocol. r FCC ID: -7077 or C s

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May 7, 2013 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Re: Medtronic, Inc. Request For Permanent Confidentiality FCC ID No.:LF519061 Ladies and Gentlemen: Medtronic, Inc. (“Medtronic”) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Commission’s Rules, 47 C.F.R. § 0.459 and 0.457, following grant of the application. In support of this request, Medtronic submits the following: (1) identification of the specific information for which confidential treatment is sought: Schematics Block Diagram Theory of Operation / Operational description The materials set forth in these exhibits, which are segregated from the non- confidential exhibits of the application, are those for which confidentiality is sought. (2) identification of the Commission proceeding in which the information was submitted or a description of the circumstances giving rise to the submission: The proceeding is that involving the certification of FCC ID No.: LF519061 (3) explanation of the degree to which the information is commercial or financial, or contains a trade secret or is privileged: This information is embodied in circuit diagrams, detailed explanations, block diagram and internal photographs of a device designed for patients under the care of a medical professional. As such, this material is treated as highly confidential business information and information that could convey trade secrets pertaining to manufacturing and design techniques. (4) explanation of the degree to which the information concerns a service that is subject to competition: The information for which confidentiality is sought is employed in the design and manufacture of medical device systems which is solely available through Clinical Study. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. (5) explanation of how disclosure of the information could result in substantial competitive harm: Equipment Authorization Branch Page 2 Disclosure would, in effect, give away the fruits of the labors of Medtronic’s engineering personnel, who have designed the equipment . Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic. (6) identification of any measures taken by the submitting party to prevent unauthorized disclosure: The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. (7) identification of whether the information is available to the public and the extent of any previous disclosure of the information to third parties: To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought. (8) justification of the period during which the submitting party asserts that material should not be available for public disclosure: This material should not be disclosed for at least five years. This application contains information that will be used in future applications for similar devices. Moreover, the communications aspects of this device are employed in the transmission of highly private medical information to the device. As such, it is important that information pertaining to the design and operation of this device not be made available to unauthorized persons who might attempt to use knowledge of the design to compromise the applications for which the equipment will be employed. Respectfully, Prin. Radio/ Telecom Regulatory Affairs Specialists Medtronic, Inc. 8200 Coral Sea St. NE Mounds View, MN 55112 Email:[email protected] Ph: (763) 526-2373

FCC Home | Search | RSS | Updates | E-Filing | Initiatives | Consumers | Find People Office of Engineering and Technology Subject: Response to Inquiry to FCC (Tracking Number 792307) (TCB) From: [email protected] Date: 5/9/2013 10:00 AM To: [email protected] Link to Federal Communications Commission Home Office of Engineering and Technology Inquiry on 05/08/2013 : Inquiry: An applicant, Medtronic Inc, has requested long term confidential treatment of their internal photos. I've attached their request for confidentiality letter. The device is a medical patient programmer that uses inductive telemetry to communicate with an approved implant (FCC ID: LF5MICSIMPLANT3). It is seeking authorization under FCC 15C. Medtronic has a history of obtaining long term confidential treatment of their internal photos. Reference: FCC ID: LF5MICSW2. Based upon this prior history, and the justification they've provided in the attached letter, we are seeking the Commission's permission to upload the internal photos as long-term confidential exhibits. We understand this would be a waiver to the policy stated in FCC KDB 726920 D02 v02, Item c. FCC response on 05/09/2013 You have permission to upload your request for confidentiality of your internal photos. Attachment Details: Request for confidentiality letter Do not reply to this message. Please select the Reply to an Inquiry Response link from the OET Inquiry System to add any additional information pertaining to this inquiry. Response to Inquiry to FCC (Tracking Number 792307) (TCB) 1 of 15/9/2013 10:05 AM

Radio Regulatory Submission External Photos 2013 20 of March Brand: Medtronic Name: Acute Human Monitor Model: 19061 Front View Top View Radio Regulatory Submission External Photos 2013 20 of March Side View Rear View Radio Regulatory Submission External Photos 2013 20 of March Bottom View

FCC ID: LF519061 This device complies with Part 15 of the FCC rules respectively. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications of any kind not expressly approved by Medtronic could void the user’s authority to operate the monitor. 2. TEXT: ARIAL, 8 PT, BOLD, BLACK LABEL, FCC ID LF519061 3-25-13 D 1 2 3 4 5 6 7 8 8 7 6 5 4 3 2 1 A B C D C B A FIXTURE DEVELOPMENT SHEET VERSION PART NUMBER SIZE MEDTRONIC, INC MINNEAPOLIS, MINNESOTA USA MEDTRONIC CONFIDENTIAL TITLE DRAFTING DATE SCALE UNLESS OTHERWISE SPECIFIED ALL DIMENSIONS ARE IN INCHES TYPE OF DO NOT SCALE PRINT UNSPECIFIED DRAWING PRACTICES PER ANSI Y14.5M, 1982 B THIS DOCUMENT IS THE PROPERTY OF MEDTRONIC, INC. AND MUST BE ACCOUNTED FOR. INFORMATION HEREON IS CONFIDENTIAL. DO NOT REPRODUCE IT, REVEAL IT TO UNAUTHORIZED PERSONS OR SEND IT OUTSIDE MEDTRONIC WITHOUT PROPER AUTHORIZATION THE CAD DATA FOR THIS PART NUMBER CAN BE MADE AVAILABLE UPON REQUEST X.X X.XX X.XXX ANGLES ± D E S I G N D O C U M E N T PP ADOBE ILLUSTRATOR ± ± ± ETADNOITPIRCSEDREV VERSION HISTORY APPROVED BYSTATUS 1.0.0 11 DICK FISHER 2.5:1 FDL00201 ACTIVE1.0.0CONTROLLED STEVE HORNBERGER 04/04/13 3. PRINTED ON BRADY TLS PCLINK THERMAL PRINTER. 4. TRIM AS/IF REQUIRED 1. MATERIAL: BRADY PTL-20-483 VINYL (2x1 INCH)

To: Whom it may concern From: Jonathan Bruss Date: January 29, 2013 Subject: Theory of Operation of Acute Human Monitor (AHM) Model Number 19061 ___________________________________________________ Theory of Operation: Telemetry B uses low-frequency, near-field magnetic telemetry using a wire wound coil placed near the implanted device for ranges up to 5 cm. The Telemetry B transmitter consists of tri-state buffers driving a tuned LC circuit. The antenna is tuned via separate capacitors for 150 kHz and 200 kHz. These capacitors are switched at the appropriate time based on the frequency of transmission. The Telemetry B receiver amplifies and filters the received differential 175 kHz PSK signal from the antenna. The receiver consists of a low noise front end differential amplifier followed by three gain stages. Following these gain stages, a comparator is used to bit-slice the analogue signal in order to send a digital signal to the DSP. Filtering and demodulation is provided by the DSP. The final receiver gain values will be determined by the minimum H-field detection requirements. The antenna is wound in a dual-opposing coil fashion, which rejects far-field magnetic noise due to cancellation of the signal. Near field signals produce a usable signal from the antenna due to the fact that they don’t completely couple to all windings on both coils, meaning there is some but not total cancellation of the signal. Transmitter Control Circuit LNA Filter AmpAmpAmp Comp Ref DSP Receiver Figure 1: Block Diagram ********************end of document********************

Medtronic Inc. Acute Human Monitor FCC 15.209:2012 Report #: MDTR0202.1 Report Prepared By Northwest EMC Inc. NORTHWEST EMC – (888) 364-2378 – www.nwemc.com California – Minnesota – Oregon – New York – Washington WTD 12.5.23 CERTIFICATE OF TEST Last Date of Test: December 21, 2012 Medtronic Inc. Model: Acute Human Monitor Emissions Test Description Specification Test Method Pass/Fail Field Strength of Fundamental FCC 15.209:2012 ANSI C63.10:2009 Pass Spurious Radiated Emissions FCC 15.209:2012 ANSI C63.10:2009 Pass Deviations From Test Standards None Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200881-0 Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 9349 W Broadway Ave. Brooklyn Park, MN 55445 Phone: (763) 425-2281 Fax: (763) 424-3469 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834E-1). This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None Barometric Pressure The recorded barometric pressure has been normalized to sea level. REV 2012.05.24 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea KCC / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. Russia GOST – Accredited by Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC to perform EMC and Hygienic testing for Information Technology products to GOST standards. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ REV 2012.08.02 MEASUREMENT UNCERTAINTY Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document WP 342. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) for each test is on each data sheet. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-1 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy (Hz) 0.12 -0.01 Amplitude Accuracy (dB) 0.49 -0.49 Conducted Power (dB) 0.41 -0.41 Radiated Power via Substitution (dB) 0.69 -0.68 Temperature (degrees C) 0.81 -0.81 Humidity (% RH) 2.89 -2.89 Field Strength (dB) 4.00 -4.00 AC Powerline Conducted Emissions (dB) 2.70 -2.70 REV 2013.01.07 LOCATIONS Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs WA01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs NC01-05,SU02,SU07 19201 120 th Ave. NE Bothell, WA 98011 (425) 984-6600 VCCI A-0108 A-0029 A-0109 A-0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834C-1 WTD 12.5.23 PRODUCT DESCRIPTION Client and Equipment Under Test (EUT) Information Company Name: Medtronic Inc. Address: 710 Medtronic Parkway, LS250 City, State, Zip: Fridley, MN 55432 Test Requested By: Jonathan Bruss Model: Acute Human Monitor First Date of Test: December 21, 2012 Last Date of Test: December 21, 2012 Receipt Date of Samples: December 21, 2012 Equipment Design Stage: Prototype Equipment Condition: No Damage Information Provi…

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photo FF 004.JPG FF 001.JPG Field Strength of Fundamental PSA-ESCI 2012.12.14 photo FF 002.JPG FF 003.JPG Field Strength of Fundamental PSA-ESCI 2012.12.14 photo FF 004.JPG FF 001.JPG Spurious Radiated Emissions PSA-ESCI 2012.12.14 photo FF 002.JPG FF 003.JPG Spurious Radiated Emissions PSA-ESCI 2012.12.14